BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS SMOOTH

    MDR report key: 19662169 · Received July 2, 2024

    Report

    Report Number
    1645337-2024-07918
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    November 1, 1997
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A H6 HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: PC-(B)(4).

    Additional Manufacturer Narrative · 0

    ON 31-MAR-2025, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. AN EVENT DATE (01-NOV-1997) WAS REPORTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED (VIA HEALTH CANADA REPORTS MDS 223323 AND MDS 223185) THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES DEVICES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING CHRONIC FATIGUE SYNDROME, MIGRAINES, NAUSEA, OCULAR MIGRAINES, IBS, WEIGHT GAIN, BRAIN FOG, VERTIGO, PANIC ATTACKS, HAIR LOSS, DRY SKIN, RINGING IN THE EARS, NIGHT SWEATS, HEART PALPITATIONS, FLU-LIKE SYMPTOMS, BREATHING PROBLEMS, SWOLLEN LYMPH NODES, TINGLING/NUMBNESS IN HANDS AND FEET, DIFFICULTY WITH READING WRITING AND SPEAKING, AND BLOOD PRESSURE ISSUES. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755931 UNKNOWN SALINE IMPLANTS SMOOTH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other